This invention relates generally to specimen cups, chemical test strips for analyzing contents of analytical specimen cups and, specifically, to analytical specimen cups which are combined with chemical test strips.
It has been suggested to combine chemical test strips with analytical specimen cups so that contents of the specimen cups can be analyzed without the necessity of opening the specimen cups and inserting chemical strips therein. For example, U.S. Pat. No. 4,827,944 to Nugent discloses a body fluid sample collection tube having a number of bores therein for allowing a sample in the tube to impregnate adjacent dry chemistry patches. A plastic film wrap is pre-shrunk over the tube and the patches so as not to allow specimen fluids to escape beyond the patches. When a specimen is introduced into the collection tube of this invention a portion of the specimen passes immediately through the bores and impregnates, simultaneously and immediately, the plurality of patches so that an analysis of the fluid specimen can be made immediately. The specimen remains thereafter in continuous contact with the patches. One difficulty with this system is that it is usually not desirable to immediately test collected body fluids when they are first placed in a specimen cup. In this regard, most chemical patches, pads or test strips are time sensitive and do not, therefore, retain appropriate test colors over even short periods of time. Similarly, if the specimen remains in continuous contact with the patches so that the patches are not exposed to air, the patches may not properly react so that their colors do not reliably change as required. Thus, a technician observing the patches cannot obtain an accurate reading therefrom.
U.S. Pat. No. 5,119,830 to Davis describes an analytical specimen cup coupled with a test strip which overcomes some of the disadvantages of Nugent (U.S. Pat. No. 4,827,944). That is, the analytical specimen cup of U.S. Pat. No. 5,119,830 to Davis has a lid with outer and inner partitions to define a test space therebetween in which a chemical test strip is mounted. A fluid specimen in a cup is selectively introduced to the chemical test strip by manipulating a frangible valve which brakes an opening in the inner partition. Thus, the analytical specimen cup described in U.S. Pat. No. 5,119,830 to Davis allows technicians to control when fluid specimen is introduced to a chemical test strip so that the technicians need only do this when they are prepared to read and record the data.
Although the device in the Davis U.S. Pat. No. 5,119,830 overcomes to some extent the "time sensitive" problem of the Nugent system it does not completely overcome the "continuous contact" problem which prevents the patches from being exposed to air. That is, once the specimen is introduced to the test strip it remains substantially in continuous contact therewith. Thus, once a technician has introduced the specimen to the test strip it may be difficult for him to properly read the test strip and/or properly record the data therefrom. Thus, it is an object of this invention, to provide an analytical specimen cup system and method which allows one to immediately take accurate data therefrom without undue difficulty.
Another difficulty, common to both Nugent (U.S. Pat. No. 4,827,944) and Davis (U.S. Pat. No. 5,119,830), is that it is difficult to sterilize their analytical specimen cups and test strips. In this regard, it is sometimes necessary that specimen cups be sterilized so that there is no bacteria therein which could affect the specimen over a longer period of time. However, most normal sterilizing methods adversely affect chemical test strips and patches. That is, if chemical test strips are sterilized along with specimen cups, the test strips no longer provide accurate analyses of specimens contained in the specimen cups. Unfortunately, both Nugent (U.S. Pat. No. 4,827,944) and Davis (U.S. Pat. No. 5,119,830) require that the test strips thereof be sterilized along with the specimen cups. Therefore, it is an object of this invention, to provide an analytical specimen cup system and method which allows a specimen cup to be sterilized while not requiring that a test strip thereof to be sterilized.
A related difficulty with the devices of both Nugent (U.S. Pat. No. 4,827,944) and Davis (U.S. Pat. No. 5,119,830) is that if their chemical test strips remain unsterilized, they automatically contaminate entire specimens placed in their cups. This is because portions of liquid specimens contacting the chemical strips thereof are allowed to then flow freely back to the specimens remaining in the specimen cups thereof. Thus, it is an object of this invention to provide an analytical cup system and method which can be used for introducing and partitioning a portion of a specimen from a specimen cup to a test strip thereof without unduly contaminating a main portion of the liquid specimen remaining in the specimen cup.
Presently, dry chemical test strips are still usually introduced into urine or other fluidic specimens by dipping them therein and then exposing them to air. Such a procedure definitely contaminates a fluid specimen, and thereby adversely affects further tests run with the fluid specimen (such as using the fluid specimen with a culture). Such chemical test strips provide visual indications of quantitative properties of a specimen fluid such as: pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, and many other fluid sample components. Changes in color of the chemical test strips are indicative of these characteristics of fluid specimens and therefore provide technicians with information as to what if any further testing may be required. When a fluid specimen and test strip are combined a technician must read the colors of the various patches of the test strip, analyze these colors, and record them on a chart. During this process, a number of mental and physical steps are required which, if not carried out accurately, can lead to the recording of false data which can, in turn, lead to serious, if not fatal, problems. Thus, it is an object of this invention to provide an analytical specimen cup system and method of its use which reduces the number of physical and mental steps required of technicians in reading and recording data.